American Dental Implant - 6.0mm x 08mm XL Diameter Tapered Internal Hex - AMERICAN DENTAL IMPLANT CORPORATION

Duns Number:835556429

Device Description: 6.0mm x 08mm XL Diameter Tapered Internal Hex Dental Implant RBM Surface

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More Product Details

Catalog Number

T6008RBM

Brand Name

American Dental Implant

Version/Model Number

T6008RBM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K042462

Product Code Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

366b7687-10c5-4378-bf79-a544bf126982

Public Version Date

August 31, 2018

Public Version Number

1

DI Record Publish Date

July 31, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMERICAN DENTAL IMPLANT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 43
2 A medical device with a moderate to high risk that requires special controls. 190